510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K844570Substantially Equivalent

Quantum 412

Keta Corp., Danvers MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K844570 is the FDA 510(k) clearance record for QUANTUM 412, a class I device, cleared for Keta Corp. on under FDA product code HPT (Perimeter, Automatic, Ac-Powered). FDA records list 3 510(k) clearances for Keta Corp., from to . As of , FDA records show no recalls naming K844570.

Clearance record

Decision date
Received
(12 days to decision)
Product code
HPT Perimeter, Automatic, Ac-Powered
Regulation
21 CFR 886.1605
Device class
Class I
Review panel
Ophthalmic
Applicant
Keta Corp. 9 Canal St., Danvers MA
Third party review
No

Clearances, product code HPT

Trailing 12 months

FDA records hold no clearances under product code HPT in the trailing twelve months.

FDA records show no clearances under product code HPT in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HPT, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260